Ivenix, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Ivenix, Inc. makes
Ivenix, Inc. makes the Ivenix Infusion System, which includes infusion pumps and related administration sets such as the LVP Epidural Administration Set with NRFit Connector.
The company's devices are classified as Class II medical devices and are listed in the FDA 510(k) registry; Ivenix, Inc. is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Ivenix Infusion System (IIS) Ref K183311
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Ivenix, Inc., initiated on 2022-04-22. By recorded status: 1 terminated. The reasons filed fall into these groups: electrical or power. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 1
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2022
- 22 Apr 2022 Z-1381-2022 Class II Terminated Downstream occlusion alarm is sometimes immediately followed by a pump problem alarm.
Frequently asked questions
How many devices does Ivenix, Inc. have in the registry?
The registry currently lists 2 devices for Ivenix, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ivenix, Inc.'s devices?
Among its 2 most recently registered devices, Ivenix, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Ivenix, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Ivenix, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Ivenix, Inc.?
FDA recall records list 1 recall initiated by Ivenix, Inc., the most recent initiated on 22 Apr 2022. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Ivenix, Inc. in the registry?
The most recently registered devices listed for Ivenix, Inc. include Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector and Ivenix Infusion System (IIS).